The production of nose drops requires scientific knowledge and precise production processes. Unlike many other pharmaceutical products, nose drops are aqueous substances that are mixed with other phases.
Special production requirements
Nose drops require special production cycles. In addition, extremely strict safety and quality criteria apply in pharmaceutical manufacturing, and quality controls take up most of the production time. The specific nature of the components makes production even more difficult.
Requirements for the agitation and homogenising plant
For production to run precisely and without quality deviations, the plant must meet all production-relevant requirements:
- identical design and performance for precise scale-up from laboratory scale to the process plant
- consistently high product quality with fast, precise process control
- aseptic valves and GMP-compliant design
- integrated cleaning in place (CIP) for sterile production and hygiene
Control and documentation
Precise documentation of all production steps is also of great importance. Solutions range from a small recipe control with a separate recorder to a large visualisation on a touch panel.
Large solutions include an integrated recipe sequence for production and cleaning steps, continuous documentation in the background and operation via a central control system. This creates the right program for every customer.
FAQ: Producing nose drops
How are nose drops produced?
Active ingredients are dissolved in an aqueous base, buffers, tonicity agents and if needed preservatives are added, the pH is adjusted, and the solution is filtered and filled under low-germ or sterile conditions.
What are the requirements for the process plant?
Aseptic valves, GMP design, dead-space-free CIP cleaning, SIP capability and precise measurement and control of pH and temperature.
How is scale-up achieved?
With laboratory and production plants of identical design and performance layout, so product quality stays the same from trial to production.
Why is documentation so important?
For GMP-compliant batch release, all production and cleaning steps are recorded automatically, from a simple recipe control to a full process control system.
Does SEEFRIED support nose drop plant projects?
Yes, with planning, qualification and suitable agitation and homogenising plants for liquid pharmaceuticals.